Pakistan Export No Objection Certificate under Rule 27

1. Key takeaways

The legal basis for Pakistan’s export No Objection Certificate (NOC) is Rule 27 of MDR 2017. One point needs particular emphasis: the current Rule 27 is the version as replaced by S.R.O. 559(I)/2022 (dated 27 April 2022), not the text as originally gazetted in 2018. Citing the old Rule 27 produces a mismatch between the provision cited and the provision actually in force.

The lesson generalises well beyond this single rule, and it applies with equal force to fees, forms, and timelines. Pakistan’s device rules have been amended repeatedly since 2018, and each amendment can relocate, renumber, or substantially rewrite a provision. A regulatory file built on citations inherited from earlier projects therefore ages silently: nothing in the file signals that the rule behind a reference has moved, been renumbered, or been rewritten with a different scope. Verifying the current version of every single cited rule — before the citation is used in a submission, a contract, or a customs document — is the only reliable safeguard. The cost of the check is minutes; the cost of a wrong citation can be a rejected application, an unenforceable contract clause, or a shipment stopped at the border while the paperwork is corrected.

2. Legal basis

The table below sets out the basis of the export NOC, the amendment that replaced the rule, and the surrounding institutional framework.

The institutional row matters for routing: the MDMC is the division through which export NOC applications and related licensing correspondence run, so correspondence and queries should be addressed within that framework rather than to the authority generically. Knowing the responsible division also tells an exporter where deficiency questions will come from and who can resolve them. Finally, the rule-making power under s.23 of the DRAP Act, 2012 is what gives the rules their binding character, which is why the amendments issued under it must be tracked with the same attention as the parent rules themselves.

3. Expert insights

Insight 1: Pakistan’s device rule amendments are frequent and come in groups. In 2022 alone there were two: S.R.O. 430(I)/2022 (amending Form 6A / 7A) and S.R.O. 559(I)/2022 (adding Rule 24A, deleting Rule 25, replacing Rule 27); in 2023 came S.R.O. 224(I)/2023 (replacing Rule 52); and in 2025 came S.R.O. 1399(I)/2025 (amending Schedule C). This is why this series repeatedly stresses verification of the current version. The cadence also implies that verification cannot be a one-off exercise at project start: a reference that was accurate at signature can be overtaken by an amendment issued before the filing that uses it. We therefore treat each new S.R.O. in the device space as an internal trigger to re-verify every affected citation across active client files, not only in new documents.

Insight 2: the import NOC and the export NOC are two different matters. The import NOC serves customs clearance (through PSW from 2026), while the export NOC serves outbound shipments (Rule 27). Their names are similar but their legal bases differ, and they must be clearly and consistently distinguished in contracts, invoices, and shipping documents alike. Confusing the two is not merely sloppy drafting: a contract clause that cites the wrong rule for the wrong certificate can leave the parties without a clear obligation to cooperate on the document that actually governs their shipment, which surfaces exactly when a consignment is waiting. The fix is cheap and preventive: name the certificate, name its rule, and date the version in every contract annex.

Insight 3: the application entry point for every segment has been unified into the portal. Since the e-DRAP / e-Service portal came online on 2025-07-21, the establishment licence, product enlistment/registration, renewal, and changes are all processed online, and paper submissions are no longer accepted at all. For export procedures this means the internal file should be assembled in portal-ready form from the start: structured documents, correct references to the current rules, and the fee challan generated through the portal, with no fallback to paper routines and no assumption that a scanned signature page can substitute for a portal submission. Exporters who maintain portal-ready templates for NOC applications find the process largely administrative; those who assemble each file from scratch rediscover the documentation requirements with every shipment, and the difference shows in their export lead times.

4. Practical recommendations

GRZAN’s first recommendation to clients on Pakistan projects is “build the register first, then discuss the process”: record every document involved (establishment licence, Form-8 / Form-8A certificates, import permit, the various NOCs) together with its issuance date and expiry date in a single register, and mark for each document the current rule version and the amending S.R.O. number it is based on. In this way, when the rules are amended again, the certificates requiring re-verification can be located quickly. The register turns each new S.R.O. from a research task into a lookup task: filter the register by the cited provision, and the affected documents list themselves. It also protects institutional memory, since the reasoning behind each version reference survives staff turnover. In our practice the register is reviewed against every new device-sector S.R.O. within days of publication, so the portfolio’s citations are never more than one amendment behind the law.

5. Verification checklist

• □ Distinguished the import NOC (PSW) from the export NOC (Rule 27)
• □ Current version of Rule 27 checked (as replaced by S.R.O. 559(I)/2022)
• □ Confirmed that all applications are submitted through the e-Services portal
• □ Document register established (issuance date, expiry date, basis reference)
• □ Five-year renewal plan scheduled

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com